Flower Orthopedics Corporation: Flex-Thread 3.2mm Cannulated Reamer Recalled for Risk of Device Breaking

Agency Publication Date: October 6, 2023

Summary

Flower Orthopedics Corporation has recalled 70 units of the Coventus Flex-Thread 3.2mm Cannulated Reamer, a surgical tool used to open the bone canal for nail insertion. The device has been reported to break while in use during surgical procedures. If the tool breaks inside a patient, it may necessitate additional surgery to remove the fragments or repair the damage.

Risk

The reamer can snap or fracture during a procedure, potentially leaving metal fragments inside the patient's body or causing internal injury that requires a revision surgery to correct.

What You Should Do

Check your surgical inventory for the Coventus Flower Orthopedics Flex-Thread 3.2mm Cannulated Reamer with Catalogue Number 8528-1-S.
Verify the Lot Number 2304323076 and UDI 00840118117432 to confirm if your specific units are affected.
Immediately stop using any affected reamers and quarantine them to ensure they are not used in medical procedures.
Contact Flower Orthopedics Corporation directly at their Horsham, Pennsylvania headquarters for instructions on returning the defective devices and obtaining replacements.
Patients who have recently undergone surgery involving this device should contact their healthcare provider if they experience unusual symptoms or have concerns about their procedure.
For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer contact for revision/replacement instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Coventus Flower Orthopedics Flex-Thread 3.2mm Cannulated Reamer

Model / REF:

8528-1-S

Lot Numbers:

2304323076

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93024

Status: Active

Manufacturer: Flower Orthopedics Corporation

Sold By: authorized medical distributors

Manufactured In: United States

Units Affected: 70 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your surgical inventory for the Coventus Flower Orthopedics Flex-Thread 3.2mm Cannulated Reamer with Catalogue Number 8528-1-S.

Verify the Lot Number 2304323076 and UDI 00840118117432 to confirm if your specific units are affected.

Immediately stop using any affected reamers and quarantine them to ensure they are not used in medical procedures.

Contact Flower Orthopedics Corporation directly at their Horsham, Pennsylvania headquarters for instructions on returning the defective devices and obtaining replacements.

Patients who have recently undergone surgery involving this device should contact their healthcare provider if they experience unusual symptoms or have concerns about their procedure.

For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.